EMS NASAL CPAP MASK

K972605 · Engineered Medical Systems · BZD · Jan 28, 1998 · Anesthesiology

Device Facts

• Record ID: K972605
• Device Name: EMS NASAL CPAP MASK
• Applicant: Engineered Medical Systems
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached.

Device Story

EMS Nasal CPAP mask covers patient nose; provides seal for positive pressure air delivery from CPAP or Bi-level systems. Device connects to patient circuit including exhalation device, 22 mm tubing, and optional humidifier/bacteria filter. Held in place by adjustable headgear. Optional foam spacers reduce headgear tension; cushion support ring stabilizes cushion wall. Used in hospital, sleep lab, or home settings; operated by patient or clinician. Output is physical interface for air delivery; facilitates therapeutic pressure application to airway. Benefits patient by enabling effective OSA treatment via positive pressure.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Silicone (cushion), Polycarbonate (cone, swivel elbow). Form factor: Nasal mask with adjustable headgear. Connectivity: Mechanical interface for 22 mm tubing. Sterilization: Not specified (intended for cleaning with soap and water). Software: None.

Indications for Use

Indicated for adults with Obstructive Sleep Apnea (OSA) requiring CPAP or Bi-level positive airway pressure therapy in hospital, sleep laboratory, or home environments.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Respironics Silicone Contour Nasal CPAP mask (K883825)

Submission Summary (Full Text)

{0}------------------------------------------------

972603

JAN 2 8 1998

# Engineered Medical Systems

### 8529 ZIONSVILLE ROAD • INDIANAPOLIS, IN 46268 • [317] 872-500 · FAX [phone]

| | page 1 of 3 |
|---------------------------------------------------------|--------------------------------------------------------|
| | July 8, 1997 |
| Engineered Medical Systems, Inc.<br>8529 Zionsville Rd. | Tel - [phone] |
| Indianapolis, IN 46268 | Fax - [phone] |
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Nasal CPAP Mask and Accessories |
| Common/Usual Name: | Face Mask |
| Classification Name: | Anesthetic Gas mask |
| Device: | EMS Nasal CPAP mask |
| Predicate Devices: | Respironics Silicone Contour Nasal CPAP mask - K883825 |

### Device Description:

The EMS Nasal CPAP mask is a mask covering the nose of a patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose. It connects to a patient circuit which contains an exhalation device, tubing and perhaps a humidifier and/or bacteria filter. It is held in place with an adjustable headgear system. It made to be cleaned by soap and water.

There are optional accessories which may assist in providing more patient comfort - Foam Spacers help to reduce excessive headgear tension and relieve pressure on the bridge of the nose and Cushion Support Ring which supports the wall of the cushion.

### Intended Use:

Same indication for the equipment to which it is the mask is attached Indicated Use --Environment of Use --Hospital and Home CPAP and Bi-level positive pressure systems, e.g. Respironics REM Star Equipment --CPAP and BiPAP Systems, with a separate exhalation device and 22 mm flexible tubing.

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## Non-Confidential Summary of Safety and Effectiveness

page 2 of 3

### July 8, 1997

#### Comparison to Predicate Devices: Devices: John Comparison

| Attribute | EMS/Nasal<br>CPAP | Respironics<br>Contour Nasal Mask<br>K883825 |
|-----------|-------------------|----------------------------------------------|
| Use | | |

Same indications as equipment to which it is

| attached such as CPAP and Bi-level devices | Yes | Yes |
|--------------------------------------------|-----|-----|
| Used on adults with OSA | Yes | Yes |
| Intended to be single patient - multi-use | Yes | Yes |
| Environment Home and Hospital | Yes | Yes |

#### Design

| Same dimensions as the predicate | Yes | Yes |
|--------------------------------------------|-----|-----|
| Offered in multiple sizes | Yes | Yes |
| Intended to be cleaned | Yes | Yes |
| Adapts to headgear | Yes | Yes |
| Separate Exhalation port / device required | Yes | Yes |
| Compatible with 22 mm tubing | Yes | Yes |
| Optional Foam Spacers | Yes | Yes |
| Optional Cushion Support Ring | Yes | Yes |

#### Materials ্ট

| Cushion made of silicone | Yes | Yes |
|---------------------------------------------------------|-----|-----|
| Cone and swivel elbow made of<br>Polycarbonate | Yes | Yes |
| Exact materials as utilized in the<br>predicate devices | Yes | Yes |

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## Non-Confidential Summary of Safety and Effectiveness

page 3 of 3

July 8, 1997

| Attribute | EMS Nasal CPAP | Respironics Contour Nasal Mask K883825 |
|----------------------------------------|----------------|----------------------------------------|
| Performance Standards / Specifications | | |
| None required under Section 514 | Yes | Yes |

Differences between Other Legally Marketed Predicate Devices

There are no significant differences between the intended device and the Respironics Silicone Contour Nasal CPAP mask approved under K883825.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 1998

Ms. Bonnie Holly Engineered Medical Systems 8529 Zionsville Road Indianapolis, IN 46268

Re: K972605 EMS Nasal CPAP Mask Regulatory Class: II (two) Product Code: 73 BZD November 28, 1997 Dated: December 2, 1997 Received:

Dear Ms. Holly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) ---inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Bonnie Holly

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callshan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 3

## INDICATIONS FOR USE

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | K972605 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EMS Nasal CPAP mask |
| Intended Use: | The EMS Nasal CPAP mask and accessories (mask, spacers, mask support ring and headgear) are used with and attached to a positive pressure air source, CPAP or Bi-level equipment, and has the Indications for Use consistent with the Indications for Use of the equipment to which it is attached. |
| Environment of use: | Hospital, sleep laboratories or home |

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Png
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number k972605

Prescription Use (Per CFR 801.109)

or

Over-the-counter use _

Revised 9/30/97 Page 8 of 31